Cancer Clinical Trials

A cancer clinical trial is a medical research study in which people participate as volunteers to test new methods of prevention, screening, diagnosis, or treatment of a disease.

Some cancer patients may fear that enrolling in a cancer trial means they have a chance of receiving no cancer treatment at all, but the reality is that patients in clinical trials receive either the best cancer treatment currently known for their cancer, or a new, and possibly more effective, therapy. Cancer clinical trials exist for all types and stages of cancer, as well as for cancer prevention.

Cancer clinical trials are conducted in doctors’ offices, cancer centers, other medical centers, community hospitals and clinics, and veterans’ and military hospitals in cities and towns across the United States and around the world. Cancer clinical trials may include participants at one or two highly specialized centers or they may involve hundreds of locations at the same time.

Cancer clinical trials are usually conducted in phases. Phase I trials evaluate safety, Phase II trials measure effectiveness, and Phase III trials test against best existing cancer treatment. Phase IV trials are conducted to further evaluate new uses or long-term effects of the treatment.

A randomized cancer clinical trial is a study in which the participants are assigned by chance to either a standard treatment group (control group) or investigational treatment group. The control group invariably receives the standard treatment currently available. Randomization in a cancer clinical trial gives each cancer patient an equal chance of being assigned to any of the groups. It is one method used to prevent bias in cancer research.

Standard therapy is the treatment that experts agree is appropriate, accepted, and widely used. Healthcare providers are obligated to provide patients with standard therapy. Standard therapy is also called standard of care or best practice. In cancer clinical trials, experimental therapy refers to a drug (including a new drug, new dose, combination with other drugs, or route of administration) or procedure that has undergone basic laboratory testing and received approval from the FDA to be tested in human subjects. A drug or procedure may be approved by the FDA for use in one disease or condition, but may be considered experimental in other diseases or conditions. Experimental therapy is also called investigational therapy.

A placebo is an inactive substance or treatment that looks the same as, and is given the same way as, an active drug or treatment being tested. The use of placebos in cancer treatment studies is very uncommon.

This misunderstanding is why some cancer patients are reluctant to enter cancer clinical trials. Placebos (also called sugar pills) are rarely used in cancer clinical trials and are never used in place of treatment. Patients who join cancer clinical trials are either given the standard of care, (best treatment available for their specific cancer) or receive a new treatment being investigated. Remember that although you are the only one who can decide whether to take part in a cancer clinical trial, your doctor and the research team provide important and valuable information about the risks and benefits of participation.

An important benefit to participating in a cancer clinical trial is the high level of patient care, as patients in cancer clinical trials are followed more closely by their doctors and nurses. This monitoring is an integral part of the cancer clinical trial process, and undoubtedly provides cancer patients with a high quality experience, whether they are in the treatment or control group.

Yes, very. Survivors who participated in a study conducted by the Coalition reported they were very satisfied with the cancer clinical trial experience, with 91% indicating they would recommend participating in a trial to a friend.